Pilot Study of Radiofrequency Ablation of Breast Cancer Lumpectomy Sites to Decrease Re-operation
18 Years
N/A
Female
Cancer of the Breast
Trial Information
Pilot Study of Radiofrequency Ablation of Breast Cancer Lumpectomy Sites to Decrease Re-operation
While RFA alone is not approved for tumor destruction in breast it is FDA-approved for
ablation of soft tissue after the breast cancer is removed. This study seeks to remove the
tumor and then ablate a tumor-free zone (margin) of tissue around the lumpectomy site
instead of removing more tissue. The primary short-term goal is to obviate the need for
re-excision in the event of close or positive margins (< 3 mm) which occurs on average in
~40 percent of the cases. Permanent pathology is only an estimation of margin status since
90% of recurrences occur at the site of the original lumpectomy. RFA ensures a sterilized
margin regardless of the accuracy of the permanent pathology.
Inclusion Criteria:
- Female, 18-100 years old
- Not pregnant or breastfeeding
- Pre-study radiologic documentation of:
- size ≤ 5 cm
- unicentric, unilateral
- suspicious mass or calcification
- BIRADS classification ≥ IV
- location of abnormality > 1 cm from skin
- Ductal or Infiltrating Ductal Carcinoma
- Grade I-III on final pathology
- Good general health
- Zubrod Performance Status of 0,1, or 2
- No previous chemotherapy
- No palpable axillary or supraclavicular lymph nodes
- If prior non-breast malignancy, must have > 5 year disease-free survival
Exclusion Criteria:
- Patient < 18 y/o or > 100 y/o
- Pregnant or breastfeeding
- Male
- Breast implants
- Multicentric disease or bilateral disease
- Lesions > 5 cm in diameter
- Lesions < 1.0 cm from the skin
- Previous prior radiation to the breast
- Need for mastectomy
- Diffuse microcalcifications (as determined by the Investigator)
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Margin Status
Outcome Time Frame:
Final surgical pathology review
Safety Issue:
No
Principal Investigator
V. Suzanne Klimberg, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Arkansas
Authority:
United States: Institutional Review Board
Study ID:
UAMS 29143
NCT ID:
NCT00571987
Start Date:
September 2004
Completion Date:
January 2014
Related Keywords:
- Cancer of the Breast
- Breast cancer
- Lumpectomy
- Radiofrequency Ablation
- Negative margins
- Breast Conserving Surgery
- Breast Neoplasms
Name | Location |
|---|---|
| University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
